HK40003063A - Peritoneal dialysate preparation and sensor system - Google Patents
Peritoneal dialysate preparation and sensor system Download PDFInfo
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- HK40003063A HK40003063A HK19126713.7A HK19126713A HK40003063A HK 40003063 A HK40003063 A HK 40003063A HK 19126713 A HK19126713 A HK 19126713A HK 40003063 A HK40003063 A HK 40003063A
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Description
Cross Reference to Related Applications
This application is a continuation-in-part application of U.S. patent application No. 15/478,569 filed on 4/2017, which claims benefit and priority to U.S. provisional application No. 62/318,173 filed on 4/2016, and the disclosure of each of which is incorporated herein by reference in its entirety.
Technical Field
The present invention relates to devices, systems, and methods for generating peritoneal dialysis solutions having a specified concentration of one or more solutes. The devices, systems, and methods use conductivity sensors, flow meters, and composition sensors to control the addition of osmotic agents and ionic concentrates into the peritoneal dialysis solution generation flow path.
Background
Peritoneal Dialysis (PD), including Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD), can be performed by the patient alone or with a caregiver in a clinic or home environment. PD differs from Hemodialysis (HD) in that the blood is not removed from the body and passed through a dialyzer, but rather a catheter is placed in the peritoneal cavity and dialysate is introduced directly into the peritoneal cavity. The patient's own peritoneum is used as a dialysis membrane to clean the blood within the patient. However, because the fluid is introduced directly into the human body, the fluid used in peritoneal dialysis solutions is typically required to be free of biological and chemical contaminants. The peritoneal dialysis solution should also contain solutes and cations at the indicated concentrations for biocompatibility and for membrane exchange.
Known systems and methods are unable to generate peritoneal dialysis solution with a particular and customizable solute concentration for infusion into a patient. Known systems and methods also fail to change the composition of the peritoneal dialysis solution based on a specified dialysis solution prescription. Importantly, known systems and methods use pre-prepared dialysate formulations that do not change based on the specific needs of the individual patient.
Accordingly, there is a need for systems and methods that are capable of producing peritoneal dialysis solutions having a particular concentration of solutes. The system and method should include sensors for measuring the solute concentration of the produced dialysate and for ensuring that the produced peritoneal dialysis solution matches the dialysate prescription.
Disclosure of Invention
A first aspect of the invention relates to a dialysate preparation system for peritoneal dialysis. In any embodiment, the dialysate preparation system can include: a first fluid line fluidly connected to the water purification module; at least one source of ion concentrate fluidly connected to the first fluid line by a first infusion line; the first infusion line having a first concentrate pump; one or more osmotic agent sources fluidly connected to the first fluid line by one or more secondary infusion lines; the secondary infusion line comprises a secondary concentrate pump forming part of one or more secondary infusion lines; wherein the at least one or more conductivity sensors are positioned in the first fluid line upstream of the first infusion line; at least one or more second conductivity sensors positioned in the first fluid line downstream of the first infusion line and upstream of the second infusion line; and at least one composition sensor is positioned in the first fluid line downstream of the one or more secondary infusion lines; the first fluid line may be fluidly connected to the integrated circulator.
In any embodiment, the system may include at least one secondary composition sensor positioned in one or more secondary infusion lines.
In any embodiment, the system can include a control system in communication with the composition sensor and the secondary composition sensor, the control system measuring the concentration of the osmotic agent at the composition sensor and the secondary composition sensor.
In any embodiment, the control system can control the flow rate of the osmotic agent based on the composition sensor and the secondary composition sensor.
In any embodiment, the system may include at least one flow meter in the first fluid line.
In any embodiment, the flow meter may be downstream of the secondary infusion line.
In any embodiment, at least two osmotic agent sources may be fluidly connected to one or more secondary infusion lines.
In any embodiment, the system may include one or more valves fluidly connecting the at least two osmotic agent sources to the secondary infusion line.
In any embodiment, the system can include a control system in communication with the conductivity sensor and the secondary conductivity sensor, the control system controlling the flow rate of the ionic concentrate based on the conductivity sensor and the secondary conductivity sensor.
In any embodiment, the system can include at least one pH sensor in the first fluid line.
In any embodiment, the composition sensor and/or secondary composition sensor may be selected from the group consisting of a refractive index sensor, an enzyme-based sensor, and a pulsed amperometric detection sensor.
In any embodiment, the system may include a second fluid line fluidly connecting the second infusion line to the sterilization module.
Features disclosed as part of the first aspect of the invention may be present in the first aspect of the invention either individually or in combination, or may follow a preferred arrangement of one or more of the described elements.
A second aspect of the invention relates to a method. In any embodiment, the method may comprise the steps of: (a) pumping water from a water source into a first fluid line through a water purification module; (b) measuring a first conductivity of the fluid in the first fluid line; (c) pumping an ion concentrate from at least one ion concentrate source into a first fluid line through a first infusion line; (d) measuring a second conductivity of the fluid in the first fluid line downstream of the first infusion line; (e) pumping an osmotic agent concentrate from an osmotic agent source into the first fluid line through the second infusion line; and (f) measuring a first osmotic agent concentration in the first fluid line downstream of the second infusion line.
In any embodiment, the method may include measuring a second osmotic agent concentration in the second infusion line.
In any embodiment, the method may include pumping fluid from the first fluid line into the sterilization module and pumping fluid from the sterilization module into the integrated circulator.
In any embodiment, the method can include receiving a dialysate prescription; and setting the ionic concentrate flow rate and the osmotic agent flow rate based on the dialysate prescription.
In any embodiment, the step of setting the ionic concentrate flow rate and the osmotic agent flow rate may be performed by a control system in communication with a first concentrate pump in the first infusion line and a second concentrate pump in the second infusion line.
In any embodiment, the controller can set the osmotic agent flow rate based on the first osmotic agent concentration and the dialysate prescription.
In any embodiment, the method can include generating an alarm if the first osmotic agent concentration exceeds a predetermined range of the dialysate prescription.
In any embodiment, the method can include generating an alarm if the second conductivity is outside a predetermined range of the dialysate prescription.
In any embodiment, at least two osmotic agent sources may be fluidly connected to the second infusion line.
In any embodiment, the method may include selecting an osmotic agent source from at least two osmotic agent sources; and pumping the osmotic agent concentrate from the selected osmotic agent source.
In any embodiment, the method may include any one or both of: a) generating an ion concentrate by pumping purified water from the sterilization module into the ion concentrate source; and/or b) generating an osmotic agent concentrate by pumping purified water from the sterilization module into the osmotic agent source.
In any embodiment, either or both of the following are present: a) the step of generating the ion concentrate may include agitating the ion concentrate after pumping the purified water into the ion concentrate source, heating the purified water before pumping the purified water into the ion concentrate source, or a combination thereof; and/or b) the step of generating the osmotic agent concentrate may include agitating the osmotic agent concentrate after pumping the purified water into the osmotic agent source, heating the purified water before pumping the purified water into the osmotic agent source, or a combination thereof.
Features disclosed as part of the second aspect of the invention may be in the second aspect of the invention alone or in combination, or follow a preferred arrangement of one or more of the elements described.
Drawings
Fig. 1 shows a peritoneal dialysis solution generation flow path with an integrated circulator.
Fig. 2 shows a system for adding concentrate to a peritoneal dialysis solution generation flow path.
Fig. 3 shows an overview of a system having a single concentrate source for generating and using peritoneal dialysis solution.
Fig. 4 shows an overview of a system having multiple concentrate sources for generating and using peritoneal dialysis solution.
Fig. 5 shows an alternative peritoneal dialysis solution generation flow path with an integrated circulator.
Fig. 6 shows a peritoneal dialysis solution generation flow path with multiple dispensing options.
Figures 7A-7D show a peritoneal dialysis solution generating cabinet having a water reservoir and a waste reservoir.
Fig. 8 shows a peritoneal dialysis solution production cabinet connected to a tap and drain.
Fig. 9 shows a peritoneal dialysis solution generation and delivery system.
Detailed Description
Unless defined otherwise, all technical and scientific terms used have the same meaning as commonly understood by one of ordinary skill in the art.
As used herein, the article "a" is intended to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. For example, "an element" means one element or more than one element.
The term "agitation" refers to mixing or otherwise moving a fluid or substance by mechanical means.
The term "communication" refers to an electronic or wireless link between two components.
A "composition sensor" is a device capable of measuring the concentration of one or more solutes in a fluid.
The term "comprising" includes, but is not limited to, anything following the word "comprising". The use of the terms indicates that the listed elements are required or required, but other elements are optional and may be present.
A "concentrate pump" is a pump configured to move fluid between a concentrate source and a flow path.
A "conductivity sensor" is a device for measuring the conductivity of a solution and/or the ionic (e.g., sodium) concentration of the solution.
The term "consisting of … …" encompasses and is limited to anything following the phrase "consisting of … …". The phrase indicates that limited elements are required or required, and that no other elements are present.
The term "consisting essentially of … …" encompasses anything after the term "consisting essentially of … …" as well as additional elements, structures, acts, or features that do not affect the basic operation of the described apparatus, structure, or method.
The term "control" refers to the ability of one component to direct the action of a second component.
A "control system" may be a combination of components that work together to maintain a system to a desired performance specification setting. The control system may use a processor, memory, and computer components configured to interoperate to maintain the desired performance specification. The control system may also include fluid or gas control components and solute control components known in the art for maintaining performance specifications.
The term "dialysate" describes a fluid into or out of which solutes from the fluid to be dialyzed diffuse through a membrane. For example, for peritoneal dialysis, solutes can diffuse through the patient's peritoneum. The dialysate may vary depending on the type of dialysis to be performed. For example, a dialysate for peritoneal dialysis can include different solutes or different concentrations of solutes than a dialysate for hemodialysis.
The term "dialysate preparation system" refers to a collection of components that are capable of generating peritoneal dialysate from component parts.
The term "dialysate prescription" refers to the concentration of one or more solutes in a peritoneal dialysis solution intended for use by a patient.
The term "downstream" refers to the position of a first component relative to a second component in a flow path, wherein during normal operation, a fluid, gas, or combination thereof will pass through the second component before the first component. A first component may be said to be "downstream" from a second component, while the second component is "upstream" from the first component.
An "enzyme-based sensor" is a component that measures the concentration of a first substance by catalytically converting the first substance to a second substance and measuring the amount of the second substance produced.
A "flow meter" is a device capable of measuring the amount or rate of fluid moving past or through a particular location.
The term "fluid" may be any substance, such as a gas or a liquid, which is not of a fixed shape and is susceptible to external pressure. In particular, the fluid may be water containing any solute in any concentration. The fluid may also be any type of dialysate, including fresh, partially used, or used.
The terms "fluidly connected," "fluidly connectable," and "fluidly connected" refer to the ability to transfer a fluid or gas from one point to another. The two points may be within or between any one or more of all types of compartments, modules, systems, and components.
"fluid line" may refer to a pipe or conduit through which a fluid, gas, or fluid containing gas may pass. The fluid line may also contain air during different modes of operation, such as cleaning or purging the line.
The term "generating" refers to producing a substance or fluid from a constituent.
The term "generating an alarm" may refer to generating a state or condition of the system or signaling it to a user.
The term "generating a peritoneal dialysis solution" refers to producing a peritoneal dialysis solution from components.
The term "heating" refers to raising the temperature of a substance, fluid, gas, or combination of fluid and gas. The term may also refer to raising the temperature of a component, such as a container or a fluid line, as described herein.
The term "infusion line" refers to a fluid line used to carry the peritoneal osmotic agent and/or cationic infusion fluid into the peritoneal dialysis solution generation flow path.
An "integrated circulator" is an assembly for moving fluid into and out of the peritoneal cavity of a patient, wherein the integrated circulator forms part of the overall system. For example, the integrated circulator may be housed in a housing with other components for peritoneal dialysis and fluidly and electrically connected to the desired components.
By "ionic concentrate" is meant one or more ionic compounds. The ionic concentrate may have one or more ionic compounds in the ionic concentrate. Furthermore, the ion concentration of the ion concentrate is greater than the ion concentration used for dialysis.
By "ion concentrate source" is meant a source of one or more ionic compounds. The ion concentrate source may be in the form of water or a solid. The ion concentrate source may further have one or more ionic compounds with an ionic concentration higher than that typically used for dialysis.
The term "measuring" may refer to determining any parameter or variable. A parameter or variable may relate to any state or value of a system, component, fluid, gas, or mixture of one or more gases or fluids.
An "osmotic agent" is a substance dissolved in water that is able to drive the net movement of water by osmosis across a semi-permeable membrane due to the concentration difference of the osmotic agent on each side of the semi-permeable membrane.
The term "osmotic agent concentration" refers to the amount of osmotic agent dissolved in a given volume of fluid.
The term "osmotic agent flow rate" refers to the rate at which fluid moves from an osmotic agent source.
"osmotic agent source" refers to a source of osmotic agent in solid and/or solution form. The osmotic agent source may interface with at least one other module found in a system for dialysis. The osmotic agent source may house at least one fluid pathway and include components such as conduits, valves, filters, or fluid connection orifices that may be fluidly connected to each other or the fluid flow pathway. The osmotic agent source may be formed as a separate housing or compartment integrally formed with the apparatus for dialysis for containing the osmotic agent source. If the osmotic agent is in solid form, the system described in the present invention can deliver a fluid, such as highly purified or sterile water, to dilute the solid osmotic agent. Optional mechanical agitation or other means such as agitation may be used to help dissolve the solid osmotic agent.
"peritoneal dialysis solution" is a dialysis solution for peritoneal dialysis that has specified purity and sterility parameters. Peritoneal dialysis solutions are different from those used in hemodialysis, but peritoneal dialysis solutions can be used for hemodialysis.
"peritoneal dialysis" is a procedure in which dialysate is infused into the peritoneal cavity, which acts as a natural dialyzer. Generally, the waste components diffuse from the patient's bloodstream via a concentration gradient across the peritoneum into the dialysis solution. Generally, excess fluid in the form of plasma water flows from the patient's blood stream through the peritoneum into the dialysis solution via an osmotic gradient. Once the infused peritoneal dialysis solution has captured a sufficient amount of the waste components, the fluid is removed. This cycle may be repeated several times a day or as needed.
A "pH sensor" is a component capable of measuring the concentration of hydrogen ions in a fluid.
The term "predetermined range" is the range of possible parameter values to be set.
A "pulsed amperometric detection sensor" is a component that measures the concentration of a substance by applying an electrical potential to a sample, causing the substance to oxidize or reduce.
The term "pump" refers to any device that causes a fluid or gas to move by applying suction or pressure.
The term "pumping fluid" refers to moving a fluid or gas through a flow path with a pump.
"purified water" may be defined as water produced by distillation, deionization, reverse osmosis or other suitable process and meeting the definition of "purified water" in the United states Pharmacopeia 23, 1 month, 1995 and FDA at 21CFR section 165.110(a) (2) (iv). Other criteria for purifying water may be determined by a person skilled in the art, in particular relating to purified water suitable for peritoneal dialysis.
A "refractive index sensor" is a component that measures the speed of light in a substance relative to the speed of light in a vacuum.
The term "secondary" as used with respect to a component is intended to distinguish two similar components and is not intended to describe the structure or function of the component described as "secondary".
The term "selecting" refers to selecting a variable or parameter from a set of possible variables or parameters.
"set," or the like, may refer to any parameter, component, or algorithm being adjusted to any particular value or position. The adjustment may include adjustment in any manner, such as positioning a component, performing a physical action, or causing any parameter, computer, algorithm, or computer to perform a particular state, whether implemented manually, by a processor, by a computer, or by an algorithm.
A "sterilization module" may be a component or collection of components that sterilize a fluid, gas, or combination thereof by removing or destroying chemical or biological contaminants.
The term "upstream" refers to the position of a first component relative to a second component in a flow path, wherein during normal operation, a fluid, gas, or combination thereof will pass through the first component before the second component. A first component may be said to be "upstream" of a second component, while the second component is "downstream" of the first component.
A "valve" may be a device capable of directing the flow of a fluid or gas by opening, closing, or blocking one or more paths to allow the fluid or gas to travel in the path. One or more valves configured to achieve a desired flow rate may be configured as a "valve assembly".
The term "water purification module" refers to an assembly capable of removing biological or chemical contaminants from water.
The term "water source" refers to a source from which potable water is available.
Peritoneal dialysis preparation and sensor system
The present invention relates to systems and methods for generating and using peritoneal dialysis solutions in peritoneal dialysis. The system for generating peritoneal dialysis solution and delivering peritoneal dialysis therapy to patient 134 can be configured as illustrated in fig. 1. The system includes a peritoneal dialysis solution generation flow path 101. Fluid from a water source, such as water tank 102, can be pumped into the peritoneal dialysis solution generation flow path 101. In addition, or as an alternative to the water tank 102, the system may use a direct connection 112 to a water source. The system pump 108 can control the movement of fluid through the peritoneal dialysis solution generation flow path 101. If a direct connection 112 to a water supply is used, a pressure regulator 113 ensures that the inlet water pressure is within a predetermined range. The system pumps fluid from a water source through the water purification module 103 to remove chemical contaminants from the fluid in preparation for producing dialysate.
The water source may be a drinking water source, including a purified water source. Purified water may refer to any source of water that has been treated to remove at least some biological or chemical contaminants. Alternatively, the tank 102 may be a non-purified water source, such as tap water, wherein water from the tank 102 may be purified by the system as described. The non-purified water source may provide water that has not been additionally purified, water that has been purified to some extent but does not meet the definition of "purified water" provided, such as bottled water or filtered water. The peritoneal dialysis solution generation flow path 101 can also have a direct connection 112 to a purified or non-purified water source, shown as direct connection 112. The water source may be any source of water, whether from a faucet, or a separate container or reservoir.
The water purification module 103 may be a sorbent cartridge. The sorbent cartridge may contain alumina to remove fluoride and heavy metals. The sorbent cartridge can have a first alumina layer, a second activated carbon layer, and a third ion exchange resin layer. The size of the sorbent cartridge may be determined depending on the needs of the user, with larger sized sorbent cartridges allowing more exchanges before the sorbent cartridge must be replaced. The sorbent cartridge can also contain activated carbon. Activated carbon is used to adsorb non-ionic molecules, organic molecules and chlorine, as well as some endotoxin or bacterial contaminants from water. In certain embodiments, the sorbent cartridge may comprise activated carbon, activated alumina, and possibly other components that act primarily by physical and chemical adsorption, as well as one or more ion exchange materials. The ion exchange material may be any material known in the art, but preferably, the ion exchange material will release hydrogen and hydroxyl ions to exchange with other cations and anions in solution, thereby forming water through the exchange process.
The sorbent cartridge may additionally comprise a microbial filter and/or a particulate filter. The microbial filter may further reduce the amount of bacterial contamination present in the fluid from the tank 102 or the direct connection 112. Optionally, an ultrafilter may be included to remove endotoxins from the fluid. Particulate filters may remove particulate matter from a fluid. Tank 102 may have any size available for the system, including between about 12 and about 25L. A 20L water tank 102 can typically produce the peritoneal dialysis solution necessary for multiple cycles. In certain embodiments, the water purification module 103 may include an optional UV light source to further purify and sterilize the water prior to adding the osmotic agent or the ionic concentrate.
Alternatively, the water purification module 103 may be any component capable of removing contaminants from water in a water source, including any one or more of an adsorbent cartridge, a reverse osmosis module, a nano-filter, a combination of cation and anion exchange materials, activated carbon, activated alumina, silica, or silica-based columns.
After the fluid has passed through the water purification module 103, the fluid is pumped to a concentrate source 104, wherein necessary components for peritoneal dialysis can be added from the concentrate source 104. The concentrate in the concentrate source 104 is used to generate a peritoneal dialysis fluid that matches the dialysate prescription. The concentrate pump 105 and concentrate valve 111 can control the movement of concentrate from the concentrate source 104 to the peritoneal dialysis solution generation flow path 101 during the controlled addition. The concentrate valve 111 may be replaced by a hose T. The hose T is a T-shaped fluid connector with an opening at each end for fluid to enter or exit the hose T. The concentrate added to the peritoneal dialysis solution generation flow path 101 from the concentrate source 104 can comprise any component prescribed for use in peritoneal dialysis solutions. Table 1 provides non-limiting exemplary ranges of common components of the peritoneal dialysis solution.
TABLE 1
| Components | Concentration of |
| Sodium chloride | 132-134mmol/L |
| Dehydrated calcium chloride | 1.25-1.75mmol/L |
| Magnesium chloride hexahydrate | 0.25-0.75mmol/L |
| Sodium lactate | 35-40mmol/L |
| Dextrose (D-glucose) monohydrate | 0.55-4.25g/dL |
| pH value | 5-6 |
| Osmolality | 346- |
To reduce the formation of Glucose Degradation Products (GDP), some peritoneal dialysis fluid systems use low GDP formulations. Exemplary peritoneal dialysate concentrations for low GDP formulations are provided in table 2. Typically, the low GDP peritoneal dialysis solution is provided in two separate bags, one of which contains calcium chloride, magnesium chloride, and glucose that are maintained at a low pH, and the second of which contains sodium chloride and buffer components, including sodium lactate and sodium bicarbonate. The two bags are mixed prior to use to produce a peritoneal dialysis solution having a neutral pH. Alternatively, a dual chamber bag may be used to prevent mixing of fluids prior to use, wherein the chambers may be separated, for example, by the walls of any type of separator.
TABLE 2
Low GDP peritoneal dialysis solution formulation
| Components | Concentration of |
| Sodium salt | 132-134mEq/L |
| Calcium carbonate | 2.5-3.5mEq/L |
| Magnesium alloy | 0.5-1.0mEq/L |
| Lactic acid | 0-40mEq/L |
| Bicarbonate salt | 0-34mEq/L |
| pH value | 6.3-7.4 |
| % glucose (g/dL) | 1.5-4.25 |
Those skilled in the art will appreciate that other components may be used in place of the components listed in tables 1 through 2. For example, dextrose as listed in table 1 is commonly used as an osmotic agent. However, other osmotic agents, including dialysate with multiple osmotic agents, can be used in addition to or in place of dextrose (including glucose, Icodextrin (Icodextrin), or amino acids). Although the sources of sodium, calcium and magnesium listed in table 1 are chloride salts, other sodium, magnesium and calcium salts, such as lactate or acetate salts, may also be used. The peritoneal dialysis solution can also contain buffering agents for maintaining the pH of the peritoneal dialysis solution, including bicarbonate buffers, acetate buffers, or lactate buffers. Although not commonly used for peritoneal dialysis, potassium chloride is available for hypokalemic patients who do not receive sufficient potassium from their diet. The concentrate source 104 may contain one or more osmotic agents, as well as one or more ionic concentrates, such as concentrated sodium chloride, sodium lactate, magnesium chloride, calcium chloride, and/or sodium bicarbonate. The concentrate source 104 may be a single concentrate source containing both the osmotic agent and the ion concentrate, or may contain multiple concentrate sources with separate sources for the osmotic agent and the ion concentrate. The system may have a single concentrate with all components mixed for day or overnight treatment for use by a single patient at home. Alternatively, the concentrate source 104 can comprise separate sources for any solutes in the peritoneal dialysis solution, each having a separate concentrate pump to add each solute. The ion concentrate source may be contained in any type of vessel or container. The ion concentrate source may be formed as a separate housing or compartment integrally formed with the apparatus for dialysis for housing the ion concentrate source.
During the controlled addition, the concentrate pump 105 pumps the concentrated solution from the concentrate source 104 to the peritoneal dialysis solution generation flow path 101. Where more than one concentrate source is used, a separate concentrate pump may move each of the concentrates into the peritoneal dialysis solution generation flow path 101, or a single concentrate pump may be used with valves configured to allow for separate control of the movement of each of the concentrate solutions to the peritoneal dialysis solution generation flow path 101.
After adding solutes from the concentrate source 104, the fluid in the peritoneal dialysis solution generation flow path 101 can contain all necessary solutes for peritoneal dialysis. The peritoneal dialysis solution should be sterile for peritoneal dialysis. The sterility level can be any level that meets applicable regulatory requirements, such as FDA required sterility assurance level 10-6This means that the chance of viable organisms after sterilization is 1 in 1,000,000 points. The system can pump fluid to the sterilization module to sterilize the peritoneal dialysis solution. As shown in fig. 1, the sterilization module may include one or more of a first ultrafilter 107, a second ultrafilter 109, and an optional UV light source 106. The sterilization module can be any component or collection of components capable of sterilizing the peritoneal dialysis solution. The sterilization module may be composed of a single or multiple ultrafilters. The number of ultrafilters may vary from one, two, three, four and more, depending on the configuration and use. Secondary components such as UV light source 106 or a microbial filter (not shown) may be used in the sterilization module to provide additional sterilization of the peritoneal dialysis solution. The sterilization module may also include at least two ultrafilters, including a second ultrafilter 109, to further sterilize the fluid and repeat the system to prevent sterilization failure. The UV light source 106 can be positioned at any location in the peritoneal dialysis solution generation flow path 101, including upstream of the ultrafilter 107, between the ultrafilters 107 and 109, or downstream of the ultrafilter 109. The ultrafilters 107 and 109 used in the sterilization module can be replaced as needed. In one non-limiting embodiment, the ultrafilters 107 and 109 can have a life of 3 to 6 months prior to replacement. However, the system does not impose a limit on the lifetime of the ultrafilter. The ultrafilters 107 and 109 can be any ultrafilter known in the art that is capable of sterilizing a peritoneal dialysis solution. Non-limiting examples of ultrafilters are available fromBellco's hollow fiber ForClean ultrafilter, Milan Dora (MO) of Italy. In certain embodiments, the sterilization module 106 may use heat sterilization. The sterilization module may contain a heater (not shown) to heat the prepared dialysate. Alternatively or additionally, the sterilization module may comprise a fast pasteurization module (not shown) to sterilize the dialysate by fast pasteurization. The sterilization module may include a heat-based sterilization component and a filtration-based sterilization component, wherein the processor, controller, or user adjusts the sterilization mode based on the usage pattern. For example, heat-based sterilization may be used when the peritoneal dialysis solution is generated for later use, while filtration-based sterilization may be used when the peritoneal dialysis solution is generated for immediate use.
The resulting peritoneal dialysis solution can be pumped directly to the integrated circulator 110 for immediate infusion into the patient 134. Alternatively, the dialysate can be pumped as a pre-prepared bolus into the optional dialysate container 114 for storage until ready for use by the patient 134. The valve 116 may control the movement of fluid to the integrated circulator 110 or dialysate container 114. The dialysate stored in the dialysate container 114 can be pumped to the integrated circulator 110 as needed by a pump 115 through a valve 117. The dialysate containers 114 can include one or more sterilized dialysate bags. After filling with peritoneal dialysis solution, the dialysate bag can be stored until needed by the patient 134. The dialysate container 114 can alternatively be a sterilized container or bag that can be reused. The reusable container or bag may be cleaned and sterilized daily or at set time periods. Alternatively, the dialysate container 114 can be any type of storage container, such as a stainless steel container. The dialysate container 114 can store enough peritoneal dialysis solution for a single infusion cycle of peritoneal dialysis solution into the patient 134, or can store enough peritoneal dialysis solution for multiple infusions into the patient 134. Additional or alternative storage containers may be included at other locations in the peritoneal dialysis solution generation flow path 101. The storage vessel may be contained upstream of the sterilization module, and downstream of the water purification module 103. Prior to use of the fluid in the circulator stage, the fluid may be pumped through a sterilization module to ensure sterility of the stored fluid. Furthermore, the concentrate may be added to the fluid before storing the fluid, or after storing the fluid but before sterilization in the sterilization module.
The storage vessel may be upstream or downstream of the concentrate source 104. Adding the concentrate to the fluid may be performed prior to storing the fluid, or immediately after storing the fluid prior to sterilization in the sterilization module.
By generating and immediately using the peritoneal dialysis solution, the storage time of the solution can be reduced, thereby reducing the likelihood of bacterial growth. The user interface may be included on a peritoneal dialysis production machine that communicates with the control system, allowing the patient 134 to direct the production of peritoneal dialysis solution as needed at selected times. Additionally or alternatively, the peritoneal dialysis solution machine can include a timer, and the timer can cause the peritoneal dialysis solution machine to generate peritoneal dialysis solution at a predetermined time according to the peritoneal dialysis schedule of the patient 134. Alternatively, the peritoneal dialysis solution generating machine can be equipped with wireless communication, such as Wi-Fi, bluetooth, ethernet, or any other wireless communication system known in the art. The user can direct the peritoneal dialysis machine to generate peritoneal dialysis solution from any location at a given time. By controlling the generation of peritoneal dialysis solution as needed using a timer, user interface, or wireless communication, the peritoneal dialysis solution storage time can be reduced, thereby reducing the chance that large amounts of degradation products are generated or bacteria are allowed to grow.
Peritoneal dialysis solution can be generated and used in real time, where it is infused directly into the patient 134 via the integrated circulator 110. For real-time generation and use of peritoneal dialysis solution, the flow rate of fluid through the peritoneal dialysis solution generation flow path 101 can be between 50 and 300 ml/min. With the described online fluid generation, a flow rate of 300ml/min may support an exchange time of 10 and 15 minutes for a complete cycle of emptying and filling the peritoneal cavity of patient 134. If the dialysate container 114 is used to store the generated peritoneal dialysis solution, the flow rate of fluid through the peritoneal dialysis solution generation flow path 101 can be any flow rate that can generate the necessary peritoneal dialysis solution. In certain embodiments, the flow rate can be at least about 15ml/min, which will produce 20L of peritoneal dialysis solution in 24 hours. The integrated circulator 110 can then infuse the generated peritoneal dialysis solution into the peritoneal cavity of the patient 134. For purposes of generating and using peritoneal dialysis solution, the integrated circulator 110 and the rest of the system can communicate to meet the needs of the patient or clinic by any method known in the art, including bluetooth, Wi-Fi, ethernet, or direct hardware connection. Additional valves and regulators (not shown in fig. 1) may be included to assist in the connection and operation of the peritoneal dialysis solution generation flow path 101 and the integrated circulator 110. The integrated circulator 110 and the peritoneal dialysis solution generation flow path 101 can communicate directly, or can each communicate with a control system to control the generation and use of peritoneal dialysis solution.
In certain embodiments, the dialysate container 114 can store enough peritoneal dialysis solution for multiple infusions into the patient 134, including peritoneal dialysis solution sufficient for treatment for one day or more. A timer can be included in the control system and can cause the machine to generate fresh peritoneal dialysis solution daily or at set times.
The integrated circulator 110 can include a metering pump 119 to meter the peritoneal dialysis solution into the peritoneal cavity of the patient 134. The in-line heater 118 heats the peritoneal dialysis solution to a desired temperature prior to infusion into the patient 134. The pressure regulator 120 ensures that the peritoneal dialysis solution pressure is within a predetermined range for safe and comfortable infusion into the patient 134. The metering pump 119 can infuse fluid into the patient 134 using any safe pressure. Typically, the pump pressure is set to 10.3kPa or 77.6mmHg on average. If there is no fluid flow, the maximum pressure may be increased to ± 15.2kPa or 113.8mmHg for a short period of time, e.g., less than 10 seconds. The peritoneal dialysis solution is infused into the peritoneal cavity of patient 134 via infusion line 124. An additional microbial filter (not shown) may be used to sterilize the peritoneal dialysis fluid just prior to its introduction into the patient 134. After the dwell period, the peritoneal dialysis solution is drained from the patient 134 through drain line 123. Pump 122 provides the driving force for removing the peritoneal dialysis solution from patient 134. Unlike the first complete cycle of the patient in an APD, treatment typically begins with emptying the peritoneal cavity of the patient 134, followed by infusion of fresh peritoneal dialysis solution into the patient 134. An optional waste reservoir 121 may be included to store used peritoneal dialysis solution for disposal. Alternatively, drain line 123 may be directly connected to a drain for direct disposal. The standard waste reservoir 121 is 15L, however, the waste reservoir 121 may be of any size, comprised between 12 and 20L. For patients requiring higher voiding volumes, a drain manifold may be included to connect multiple waste reservoirs. There is no set rate of drainage of peritoneal dialysis solution from the peritoneal cavity of the patient 134, and any flow rate can be used with the integrated circulator 110.
Various sensors positioned in the peritoneal dialysis solution generation and infusion system ensure that the fluid generated is within predetermined parameters. The flow meter 135 ensures that the incoming water is at the correct flow rate, while the pressure sensor 136 ensures that the incoming water is at the proper pressure. The conductivity sensor 125 is used to ensure that the water leaving the water purification module 103 has been purified to a level that is safe for peritoneal dialysis. The conductivity sensor 126 ensures that the conductivity of the dialysate is within a predetermined range after the concentrate from the concentrate source 104 is added. The refractive index sensor 127 ensures that the concentration of the penetrant is within a predetermined range. The pH sensor 128 ensures that the pH of the peritoneal dialysis solution is within a predetermined range. After the peritoneal dialysis solution passes through the sterilization module comprising the second ultrafilter 109, a pH sensor 129 and a conductivity sensor 130 are used to ensure that no change in pH or conductivity occurs during the purification or storage of the dialysis solution in the dialysate container 114. The integrated circulator 110 has a flow meter 131, a pressure sensor 132, and a temperature sensor 133 to ensure that the dialysate infused into the patient 134 is within the proper flow rate, pressure, and temperature ranges. The flow meter 131 may also calculate the volume of solution infused into the patient 134. The pressure sensor 132 may monitor the pressure in the peritoneal cavity.
Overfill or excess solution in the peritoneal cavity beyond the target volume may present complications in the treatment. Overfill can be caused by a number of factors, including the failure to completely empty the peritoneal cavity prior to infusion of fresh peritoneal dialysis solution. In any embodiment, the integrated circulator 110 can begin treatment with a drain step to ensure that the peritoneal cavity is free of peritoneal dialysis solution. Monitoring both the pressure and volume of the peritoneal dialysis solution introduced into the patient 134 can avoid overfilling. If the pressure rises to a certain point, the system can be programmed to end the fill or send an alert to the user to complete the desired level of peritoneal cavity fill. The volume of peritoneal dialysis solution extracted from patient 134 and introduced into patient 134 can also be monitored with a flow meter to ensure that the exchange volume is correct. The peritoneal cavity can be emptied in a similar manner by monitoring the pressure and volume of the drained peritoneal dialysis solution.
As illustrated in fig. 1, the necessary solutes can be added to the peritoneal dialysis solution generation flow path 101 from a single concentrate source 104. As shown in table 1, solutes can be present in the concentrate source 104 in a concentrated form at a fixed ratio for peritoneal dialysis. The use of a single concentrate source 104 for all solutes results in a fixed ratio for each solute of the peritoneal dialysis solution.
Table 3 provides exemplary non-limiting ranges of solutes that can be added to the peritoneal dialysis solution generation flow path 101 from a single concentrate source 104, including the starting concentrations of solutes in the concentrate source, as well as exemplary final volumes of solutes in the dialysate, and exemplary flow rates of both solutes and water in the peritoneal dialysis solution generation flow path 101, which ranges will achieve those concentrations. The solutes shown in table 3 are conventional peritoneal dialysis solution solutes. Table 4 shows exemplary ranges of solutes that can be used as low GDP formulations. Table 5 shows exemplary ranges of solutes that can be used as osmotic agents with icodextrin. Icodextrin is sometimes used as an osmotic agent over long residence periods. If dextrose or glucose is used during a long dwell period, then re-absorption of the ultrafiltrate may occur, thereby reducing the net volume of liquid removed. Icodextrin results in prolonged sustained ultrafiltration and can provide improved ultrafiltration efficiency over long residence periods. Those skilled in the art will appreciate that the concentration of any of the solutes shown in tables 3-5 can be varied by varying the flow rate of the system pump 108 or the concentrate pump 105. However, if a single concentrate source 104 is used, the ratio of solutes included is fixed. If for any reason it is desired to change the ratio of solutes, a new concentrate solution may be required.
TABLE 3
Exemplary solutes for addition from a single concentrate source
TABLE 4
Exemplary solute ranges in Low GDP solutions
| Components | Concentration (g/l) | Volume of solution (ml/L) | Flow Rate (ml/min) |
| Glucose | 100-900 | 50-400 | 1-18 |
| Sodium chloride | 13-108 | 50-400 | 1-18 |
| Sodium lactate | 11-90 | 50-400 | 1-18 |
| MgCl2.6H2O | 0.13-1.02 | 50-400 | 1-18 |
| CaCl2.2H2O | 0.6-5.1 | 50-400 | 1-18 |
| Water (W) | 600-950 | 50-1000 |
TABLE 5
Exemplary solute ranges in icodextrin solutions
| Components | Concentration (g/l) | Volume of solution: (ml/L) | Flow Rate (ml/min) |
| Icodextrin | 100-850 | 100-400 | 2-37 |
| Sodium chloride | 13-108 | 100-400 | 1-18 |
| Sodium lactate | 11-90 | 100-400 | 2-37 |
| MgCl2.6H2O | 0.13-1.02 | 100-400 | 2-37 |
| CaCl2.2H2O | 0.6-5.1 | 100-400 | 2-37 |
| Water (W) | 600-900 | 50-1000 |
Although the use of a single concentrate source 104 in the system requires a fixed ratio of solutes in the produced peritoneal dialysis solution, the single concentrate source 104 provides certain advantages. The storage requirements are reduced because only a single concentrate solution needs to be stored for a given dialysate prescription. Adding solutes to the dialysate in the correct amounts also presents a lower risk of patient error. A single concentrate source 104 also requires fewer supplies, fewer pumps, and less hardware. Furthermore, because fewer containers are required, the containers are easier to manage, clean, and sterilize. Higher concentrations of solute in the concentrate source 104 will allow for minimization of vessel size and maximization of source water used in PD solution preparation, thereby reducing costs. The limiting factor is the mutual solubility of the components, which is generally limited by the solubility of glucose or icodextrin. The flow rate of the source water can be optimized to adjust the time required to prepare the solution. In the case of on-demand dialysate preparation, high flow rates are required to minimize the time required to prepare the solution. The flow rate limit may be controlled by the metering accuracy of the concentrate pump 105 at a rate required to match the feedwater. For a single concentrate source 104, about 150 ml/exchange may be required, which corresponds to about 600 ml/day or 4.2L/week. The size of the concentrate source 104 may be determined depending on the needs of the user, with larger concentrate sources requiring less frequent refills.
The system may also include an additional waste reservoir (not shown in fig. 1) to collect any waste fluid generated by the water purification module 103 or other components. Alternatively, the waste reservoir 121 may also be used to collect any waste fluid generated by the water purification module 103 or other components. The waste reservoir 121 collects effluent generated during disinfection and/or effluent generated by a purification module, such as a reverse osmosis system.
If the components of the peritoneal dialysis solution generation flow path 101 and integrated circulator 110 are to be reused, the peritoneal dialysis solution generation flow path 101 and integrated circulator 110 can be sterilized by an on-board sterilizing fluid. The fully disposable peritoneal dialysis solution generation flow path 101 may not require sterilization. The peritoneal dialysis solution generation flow path 101 and integrated circulator 110 can be configured to form a circuit by connecting the portion of the peritoneal dialysis solution generation flow path 101 that is connected to the water tank 102 or direct connection 112 to the water source up to the infusion line 124. The disinfecting solution can be introduced into the peritoneal dialysis solution generation flow path 101 and recirculated through the fluid lines by system pumps 108 and 119. Alternatively, after disconnecting the integrated circulator 110 from the peritoneal dialysis solution generation flow path 101, the peritoneal dialysis solution generation flow path 101 and the integrated circulator 110 can be sterilized separately. The disinfecting solution may be a citric acid solution, a peracetic acid solution, a bleaching solution, or any other disinfecting solution known in the art. The disinfectant may be circulated through the flow circuit and heated. The sterilizing agent can be heated to any temperature that is capable of sterilizing the system, including temperatures of at least 80 ℃ or higher. The disinfectant may be introduced into the flow circuit and recirculated at elevated temperatures to ensure complete disinfection.
Solutes can be added to the peritoneal dialysis solution generation flow path 201 from two or more separate concentrate sources, as shown in fig. 2. The peritoneal dialysis solution generation flow path 201 can be fluidly connected to a water source and a water purification module upstream of the concentrate sources 202-206, as well as a sterilization module, an integrated circulator, and optionally a dialysate container downstream of the concentrate sources 202-206, as illustrated in fig. 1. For clarity, fig. 2 omits these components.
As illustrated in fig. 2, the concentrate sources 202-206 can include one or more ionic concentrate sources, such as a sodium chloride source 202 containing sodium chloride to be added to the peritoneal dialysis solution generation flow path 201 by way of a concentrate pump 207 through a valve 212 during controlled addition, a sodium lactate source 203 containing sodium lactate to be added to the peritoneal dialysis solution generation flow path 201 by way of a concentrate pump 208 through a valve 213 during controlled addition, a magnesium chloride source 204 containing magnesium chloride to be added to the peritoneal dialysis solution generation flow path 201 by way of a concentrate pump 209 through a valve 214 during controlled addition, and a calcium chloride source 205 containing calcium chloride to be added to the peritoneal dialysis solution generation flow path 201 by way of a concentrate pump 210 through a valve 215 during controlled addition. Those skilled in the art will appreciate that other ions may be used in the formulation of the peritoneal dialysis solution, and the ions may each be contained in separate ion concentrate sources or combined into one or more combined ion concentrate sources. The concentrate source also includes one or more osmotic agent sources, such as a dextrose source 206 containing dextrose to be added to the peritoneal dialysis solution generation flow path 201 by way of a concentrate pump 211 through a valve 216. Either of the concentrate pumps may contain a flow meter to control the addition of solutes. In addition to the source of dextrose 206 or in place of the source of dextrose 206, a source of glucose and/or a source of icodextrin may be used. A variety of osmotic agents may be added to the peritoneal dialysis solution generation flow path 201 from one or more osmotic agent sources. Those skilled in the art will appreciate that other solutes may be used instead of or in addition to those illustrated in fig. 2. A control system in electronic communication with each of the concentrate pumps can control the movement of fluid from the concentrate source to the peritoneal dialysis solution generation flow path 201. The amount of each of the concentrates that move into the peritoneal dialysis solution generation flow path 201 can be controlled to produce a peritoneal dialysis solution with a prescribed solute concentration, as determined by a doctor or health care provider. Valves 212-216 may optionally be replaced with a hose tee with additional components to prevent backflow into the concentrate source line without the use of that particular line. Optional sensors 217, 218, 219 and 220 ensure that the solute concentration in the dialysate is at the correct level after each addition. The sensors 217 to 220 may be any type of sensor suitable for confirming the delivery of the concentrate, such as conductivity sensors. An optional pH sensor 221 may be used to ensure that the pH is at the proper level after the addition of sodium lactate or other buffer. Optional refractive index sensor 222 ensures that the dextrose concentration in the dialysate is at a prescribed level. Additional sensors may be included upstream of the sodium chloride source 202 to sense the conductivity of the water prior to addition of the concentrate. Those skilled in the art will appreciate that additional sensor arrangements may be used in the described system. Any number of sensors may be included to monitor peritoneal dialysis solution concentration, including 1, 2, 3, 4, 5, 6, 7 or more sensors. The concentrate source may contain the solute in the form of a solid, powder, or solution. A source of soluble solids or powdered solutes is generated by the system by drawing fluid from the peritoneal dialysis solution generation flow path 201 into the concentrate source to generate a solution having a known concentration, such as a saturated solute solution. During the process of solute dissolution, solid or powdered solute may be dissolved using mechanical agitation of the concentrate, vibration, heating of the concentrate, or other auxiliary forms. As explained, the resulting solution is added to the peritoneal dialysis solution generation flow path. Although shown in fig. 2 as a refractive index sensor 222, those skilled in the art will appreciate that alternative methods of measuring the concentration of the osmotic agent may be used, including enzyme-based sensors or pulsed amperometric detection. An enzyme-based sensor can detect the concentration of the osmotic agent in the dialysate. Enzyme-based sensors use enzymes that are capable of oxidizing an osmotic agent such as glucose or dextrose. The enzyme is immobilized on an electrode and covered in a membrane through which the osmotic agent can pass. The electrodes are used to electrochemically measure changes in an oxidizing agent such as oxygen or glucose oxidation products such as hydrogen peroxide. Alternatively, electron transfer between the electrode and the enzyme can be detected with a mediator, such as ferrocene, to facilitate electron transfer. Alternatively, the penetrant may be detected by a pulsed amperometric detection sensor (PAD). PAD can detect glucose by applying a positive potential to the sample, resulting in oxidation of the glucose. The oxidation products adsorb on the electrode and are then desorbed by applying a more positive potential. Applying a more positive potential results in the formation of an oxide layer on the electrode, resulting in passivation of the electrode surface. The catalytic activity of the electrode is then restored by applying a more negative potential, resulting in dissolution of the oxide layer.
Although illustrated in fig. 1 as a single concentrate source and in fig. 2 as five separate concentrate sources, one skilled in the art will appreciate that any number of concentrate sources may generate a peritoneal dialysis solution, including 1, 2, 3, 4, 5, 6, 7 or more concentrate sources. Any two or more of the individual concentrate sources illustrated in fig. 2 may be combined into a single solute source, for example, by combining all or some of the ion concentrate sources into a single ion concentrate source, wherein the mixed contents do not cause the mixed concentrate to precipitate. Although each concentrate source is illustrated in fig. 2 as having a separate concentrate pump and fluid line, those skilled in the art will appreciate that more than one concentrate source may use a single pump and fluid line with valves disposed thereon to control the addition to the peritoneal dialysis solution generation flow path 201.
The concentrate sources 202 through 206 may be single-use concentrate sources or disposable concentrate sources. A disposable source of concentrate is used for a single peritoneal dialysis solution generation procedure and then disposed of. The multi-use concentrate source is reused and refilled with solute as needed.
Table 6 provides exemplary non-limiting ranges within which a separate osmotic agent source (glucose in table 6) and a separate ion concentrate source containing sodium chloride, sodium lactate, magnesium chloride, calcium chloride, and sodium bicarbonate can be used to add solutes to the peritoneal dialysis solution. Because glucose is added separately from the ionic concentrate, the ratio of glucose to other solutes can vary depending on the needs of the patient.
TABLE 6
Exemplary ranges of solutes in a dual concentrate source system
| Components | Concentration (g/l) | Volume of solution (ml/L) | Dialysate composition |
| Part A | |||
| Glucose | 850 | 6-53 | 0.55-4.5g/dL |
| Part B | |||
| NaCl | 269 | 20 | 92mmol/L |
| Sodium lactate | 84 | 20 | 15mmol/L |
| MgCl2.6H2O | 5 | 20 | 0.5mmol/L |
| CaCl2.2H2O | 18 | 20 | 2.5mmol/L |
| NaHCO3 | 105 | 20 | 25mmol/L |
| Water (W) | 927-979 | 56.10 |
By using multiple concentrate sources, a greater degree of personalization and treatment customization can be achieved for each patient. In the case of a single concentrate source, all solutes in the resulting peritoneal dialysis solution must be present in a fixed ratio. By using more than one source of concentrate, the ratio of solutes used in the peritoneal dialysis solution can be varied because the concentration of each of the osmotic agent and ionic solutes can be individually controlled. For example, as illustrated in table 6, with a single source of ionic concentrate and a single source of osmotic agent, a peritoneal dialysis solution can be generated with more or less osmotic agent per ionic concentration, providing the ability to adjust the tonicity of the peritoneal dialysis solution independently of the electrolyte composition to meet UF needs of any patient with a single set of solutions, and allowing for better control of ultrafiltration. The ultrafiltration rate resulting from the use of the peritoneal dialysis solution can be varied by changing the concentration of the osmotic agent independently of the ionic solutes, or by changing the osmotic agent used. As the system is not limited to discrete glucose or other osmotic agent concentrations, as known in commercial solutions; the system can customize the peritoneal dialysis solution to meet the patient's ultrafiltration needs as determined by the healthcare provider. As illustrated in Table 6, the glucose content in the peritoneal dialysis solution can vary between 0.55g/dL and 4.5g/dL while keeping the electrolyte and buffer components constant, allowing the system to cover the range of glucose formulations currently commercially provided using a single part A and part B composition.
In certain embodiments, two osmotic agent sources may be used, such as a source of dextrose and a source of icodextrin. With two osmotic agent sources, one can use dextrose for CAPD during daytime exchanges and icodextrin during nighttime stays to remove higher UF from icodextrin. Conversely, dextrose may be used during night-time stays, and icodextrin may be used in APD systems for extended day stays.
By using separate concentrate sources for each solute, complete personalization of the concentration and ratio of solutes in the peritoneal dialysis solution can be achieved. Table 7 provides exemplary ranges of solutes that can be used in the peritoneal dialysis solution prepared by the system, wherein each solute is in a separate concentrate source. An advantage of using separate concentrate sources for each solute is that almost any peritoneal dialysis solution composition can be prepared from a single component formulation. A system with separate concentrate sources for each solute is suitable for patients who regularly change their prescription due to diet or other factors. If only one or two concentrate sources are used, these patients need to store multiple formulations and the risk of error is increased.
TABLE 7
Exemplary dialysate compositions from Multi-Source systems
One or more concentrate sources can be removed from the rest of the system for sterilization. The concentrate source may also be sterilized each time the concentrate source is filled with a new concentrate solution. In addition, the concentrate source can be sterilized after a set number of uses, or after a set period of time. In addition, the concentrate source and the rest of the peritoneal dialysis solution generation system can be sterilized without any components by passing a sterilizing fluid, such as citric acid, peracetic acid, or bleaching solution, through all of the lines and containers of the system.
Fig. 3 illustrates an overview of generating a peritoneal dialysis solution according to any embodiment of the present invention. As explained, water from the water source 301 may be purified by the water purification module 302. A concentrate from a single concentrate source 303, which may contain an ionic concentrate and one or more osmotic agents, may be added to the purified water to generate a non-sterile peritoneal dialysis solution 304. The non-sterile peritoneal dialysis solution 304 is sterilized by a sterilization module 305, and the sterilization module 305 can include an ultrafilter (not shown). As explained, the peritoneal dialysis solution can be further purified by additional components in the sterilization module 306, such as by ultrafiltration with a second ultrafilter, through a microbial filter, or by an optional UV light source, to produce a sterilized peritoneal dialysis solution 307. The sterilized peritoneal dialysis solution 307 can be stored or used by any method described herein, including by immediate infusion of the peritoneal dialysis solution into the patient 308, or dispensing of the peritoneal dialysis solution into a dialysate container for later use in peritoneal dialysis 309, as illustrated in fig. 1.
Fig. 4 illustrates an overview of generating a peritoneal dialysis solution with multiple concentrate sources. As explained, water from the water source 401 may be purified by the water purification module 402. A concentrate from an ion concentrate source 403, which may contain sodium, magnesium, calcium, and bicarbonate, as well as any other ions to be used in peritoneal dialysis, may be added to the purification fluid. An osmotic agent, such as dextrose, may be added from the first osmotic agent concentrate source 404. A second osmotic agent, such as icodextrin, may be added from a second osmotic agent concentrate source 405. As illustrated in fig. 2, the peritoneal dialysis solution can be further personalized using any number of concentrate sources, including separate sources for each ion used. After addition of the ion and osmotic agent concentrates, the fluid contains all the necessary components for peritoneal dialysis as an unsterilized peritoneal dialysis solution 406. The non-sterile peritoneal dialysis solution 406 can be sterilized by a sterilization module 407, and the sterilization module 407 can include an ultrafilter or other sterilization component. The peritoneal dialysis solution can be further sterilized by sterilization module 408, by ultrafiltration with a second ultrafilter, a microbial filter, or further sterilized with an optional UV light source to produce sterilized peritoneal dialysis solution 409. The sterilized peritoneal dialysis solution 409 can be stored or used by any method described herein, including by immediate infusion of the peritoneal dialysis solution into the patient 410, or dispensing of the peritoneal dialysis solution into a dialysate container for later use in peritoneal dialysis 411, as illustrated in fig. 1.
Fig. 5 illustrates an alternative peritoneal dialysis solution generation flow path 501 with an integrated circulator 539. Water from a water source 502 may be pumped through a filter 503 by a system pump 504. The filter 503 may remove any particulate matter from the water prior to entering the peritoneal dialysis solution generation flow path 501. The water is then pumped through a water purification module, illustrated in fig. 5 as a sorbent cartridge 506. As described, the water purification module may alternatively or additionally comprise activated carbon, a reverse osmosis module, a carbon filter, an ion exchange resin and/or a nanofilter. Water enters sorbent cartridge 506 through sorbent cartridge inlet 507 and exits through sorbent cartridge outlet 508. Pressure sensor 505 measures the pressure on sorbent cartridge 506. Filter 509 removes any particulate matter from the fluid after exiting sorbent cartridge 506. Conductivity sensor 510 determines the conductivity of the fluid exiting sorbent cartridge 506 to ensure that the water has been purified. To generate the peritoneal dialysis solution, concentrate is added from a concentrate source 513 by means of a concentrate pump 515 through a concentrate connector 514. Although shown as a single concentrate source 513 in fig. 5, the concentrate may be added from any number of separate concentrate sources. The concentrate filter 512 removes any particulate matter from the concentrate prior to entering the peritoneal dialysis solution generation flow path 501. The conductivity sensor 516 determines the conductivity of the peritoneal dialysis solution generated after the concentrate is added to ensure that the peritoneal dialysis solution has the correct solute concentration. The flow meter 511 determines the flow rate of the fluid after the concentrate is added. The pH sensor 524 determines the pH of the peritoneal dialysis solution to ensure that the peritoneal dialysis solution has the proper pH. The peritoneal dialysis solution can be heated to a desired temperature by heater 525. The temperature sensor 528 ensures that the peritoneal dialysis solution is heated to the appropriate temperature prior to infusion into the patient 538. The heater 525 may be placed at any location in the flow path prior to delivery to the patient 538. In any embodiment, the heater 525 may be located after the outlet of the sterilization module, particularly where the fluid is stored prior to passing through the sterilization module. The desired temperature of the peritoneal dialysis solution can be between about 20 c and about 41 c. As used herein, about 20 ℃ may comprise between 19.0 ℃ and 21.0 ℃, and about 41 ℃ may comprise between 39.0 ℃ and 41.0 ℃, or similar temperatures as understood by those of skill in the art. In certain embodiments, the desired temperature may be between about 25 ℃ to about 40 ℃, about 36.5 ℃ to about 37.25 ℃, about 25 ℃ to about 35 ℃, or about 30 ℃ to about 40 ℃. In a preferred embodiment, the desired temperature may be 37 ± 2 ℃.
As described, the peritoneal dialysis solution is sterilized by pumping the peritoneal dialysis solution through a sterilization module that can include a first ultrafilter 518, and optionally a second ultrafilter 520 and/or an optional UV light source (not shown). A pressure sensor 517 measures the fluid pressure before the fluid enters the sterilization module, shown as ultrafilters 518 and 520, and is used in the control circuit to control the pressure. The fluid passes through the first ultrafilter 518, through the valve 519, and then through the second ultrafilter 520. Connector 523, three-way valve 521, and valve 519 allow for backwashing and disinfection of ultrafilters 518 and 520. The fluid is then pumped into an integrated circulator 539 for peritoneal dialysis. As described, the system can include a dialysate container (not shown) to store the generated peritoneal dialysis solution until the patient 538 is used at any location, including upstream or downstream of the sterilization module.
The integrated circulator 539 includes an infusion line 531 and a drain line 533. The bubble trap 526 collects bubbles present in the heated dialysate. Air is exhausted from the system through the bubble trap valve 527. Pressure sensor 529 ensures that the pressure of the fluid is within a predetermined range. In certain embodiments, the predetermined range may be a pressure between-200 mm Hg to 500mmHg, -50mm Hg to 100mmHg, 0mmHg to 100mmHg, -50mmHg to 200mmHg, 200mmHg to 500mmHg, or 100mmHg to 400 mmHg. The infusion line 531 is connected to a three-way valve 530, which three-way valve 530 controls the movement of fluid between the infusion line 531, the patient 538 and the drain line 533. Three-way valve 530 is connected by connector 532 to a catheter inserted into the peritoneal cavity of patient 538. A filter 522 may be included between the three-way valve 530 and the catheter to additionally clean the peritoneal dialysis solution prior to entry into the patient 538. In any embodiment, the filter 522 may be a disposable filter. The peritoneal dialysis solution is infused into the patient 538 and held for a dwell period. After the dwell period, fluid is pumped from the peritoneal cavity of the patient 538 by the drain pump 536. The three-way valve 530 is switched to direct fluid into the drain line 533. Pressure sensor 534 measures a pressure map of the fluid in drain line 531 to ensure proper drainage. Flow meter 535 measures the flow rate and volume of fluid removed from patient 538. Drain line 531 is connected to a drain or waste reservoir 537 via connector 540 to collect and dispose of the used peritoneal dialysis solution.
To self-sterilize the system, connector 540 may be connected to connector 523 to form a flow circuit. The disinfectant may be circulated through the flow circuit and heated. When citric acid is used as the disinfecting agent, the disinfecting agent can be heated to any temperature that is capable of disinfecting the system, including temperatures at least about equal to 80 ℃ or higher (80 or greater). The system can be sterilized at room temperature using peracetic acid or bleach. The disinfectant may be introduced into the flow circuit and recirculated at elevated temperatures to ensure complete disinfection. The disinfectant used may be any suitable disinfectant known in the art, including peracetic acid, citric acid, or a bleaching agent. The connectors and components of the system may be gamma and autoclave compatible to withstand the high temperatures used during sterilization. The system can be primed by introducing a priming fluid into the peritoneal dialysis solution generation flow path 501 and the integrated circulator 539.
Fig. 6 illustrates an alternative embodiment of the system. Fluid from a water source, such as water tank 602, can be pumped into the peritoneal dialysis solution generation flow path 601. In addition, or as an alternative to the water tank 602, the system may use a direct connection to the water source 612. The system pump 608 can control the movement of fluid through the peritoneal dialysis solution generation flow path 601. If a direct connection to the water supply 612 is used, the pressure regulator 613 may ensure that the water inlet pressure is within a predetermined range. The system pumps fluid from the water source 602 or 612 through the water purification module 603 to remove chemical contaminants from the fluid in preparation for producing dialysate.
After the fluid passes through the water purification module 603, the fluid is pumped to a concentrate source 604, where the necessary components for performing peritoneal dialysis can be added from the concentrate source 604. The concentrate in the concentrate source 604 is used to generate a peritoneal dialysis solution that matches the dialysis solution prescription. The concentrate pump 605 and concentrate valve 611 can control the movement of concentrate from the concentrate source 604 to the peritoneal dialysis solution generation flow path 601 during the controlled addition. Alternatively, the enrichment valve 611 may be a hose T or a return-flow limiting hose T. The concentrate added to the peritoneal dialysis solution generation flow path 601 from the concentrate source 604 can contain the components required for the peritoneal dialysis solution. After adding solutes from the concentrate source 604, the fluid in the peritoneal dialysis solution generation flow path 601 can contain all necessary solutes for peritoneal dialysis. The peritoneal dialysis solution should be brought to the sterile level of peritoneal dialysis as described. As shown in fig. 6, the sterilization module may include one or more of a first ultrafilter 607, a second ultrafilter 609, and a UV light source 606.
The generated peritoneal dialysis solution can be pumped directly to the integrated circulator 610 for immediate infusion into the patient 634. Alternatively, the dialysate can be pumped as a pre-prepared bolus to the optional dialysate container 614 for storage until ready for use by the patient 634. The valve 616 may control the movement of fluid to the dialysate container 614. Dialysate stored in dialysate container 614 can be pumped back into peritoneal dialysis solution generation flow path 601 via valve 617 via pump 615 as needed. The dialysate container 614 can store sufficient peritoneal dialysis solution for a single infusion of peritoneal dialysis solution into the patient 634, or can store sufficient peritoneal dialysis solution for multiple or continuous infusions into one or more patients.
The resulting peritoneal dialysis solution can be pumped to valve 637. Valve 637 can control the movement of the peritoneal dialysis solution to any of three options. First, the peritoneal dialysis solution can be pumped to the integrated circulator 610, second, the peritoneal dialysis solution can be diverted for use with a non-integrated external circulator 639, or third, the peritoneal dialysis solution can be diverted to the dialysate container 640. All three options can be simultaneouslyOr alternatively. If diverted to non-integrated external circulator 639, the peritoneal dialysis solution can be pumped via valve 638. The valve 638 can control the movement of the peritoneal dialysis solution by a direct connection to the external circulator 639 or to the dialysate container 640. The present invention encompasses alternative valve and pump configurations for performing the same function. For example, a direct connection to the external circulator 639 may use any type of connector known in the art. The connector may be a single use or reusable connector and should provide sterile transfer of fluids. The connector should preferably be a closed connector to avoid contact between the fluid and the external environment. A non-limiting example of a connector that may be used to directly connect to an external circulator is that provided by Medinstinl Development LLC of Delaware, USAA connector is provided. The dialysate container 640 can be heated with an optional heater 641 and then used for peritoneal dialysis. The connector to the dialysate container 640 can be any type of connector known in the art. The connector may be a single use or disposable connector that provides for the transfer of sterile fluid. Non-limiting examples of connectors that can be used with the described system are commercially available from Merck KGaA, Damschtatt, GermanyA connector is provided.
The integrated circulator 610 can include a metering pump 619 to meter the peritoneal dialysis solution into the peritoneal cavity of the patient 634. The heater 618 heats the peritoneal dialysis solution to a desired temperature prior to infusion into the patient 634. Pressure regulator 620 ensures that the peritoneal dialysis solution pressure is within a predetermined range that can be safely infused into patient 634. The metering pump 619 can be used to infuse fluid into the patient 634 at any safe pressure. Typically, the pump pressure is set to 10.3kPa or 77.6mmHg on average. If there is no fluid flow, the maximum pressure may be increased to ± 15.2kPa or 113.8mmHg for a short period of time, e.g., less than 10 seconds. The peritoneal dialysis solution is infused into the peritoneal cavity of patient 634 via infusion line 624. After the dwell period, the peritoneal dialysis solution is drained from the patient 634 through drain line 623. The pump 622 provides the driving force for removing the peritoneal dialysis solution from the patient 634. An optional waste reservoir 621 may be included to store the used peritoneal dialysis solution for disposal. Alternatively, drain line 623 may be directly connected to a drain for direct disposal. The waste reservoir 621 may be of any size, including between about 12 and about 25L. For patients requiring higher voiding volumes, a drain manifold may be included to connect multiple waste reservoirs.
Various sensors positioned in the peritoneal dialysis solution generation and infusion system ensure that the fluid generated is within predetermined parameters. The flow meter 635 ensures that the incoming water is at the correct flow rate, while the pressure sensor 636 ensures that the incoming water is at the proper pressure. Conductivity sensor 625 is used to ensure that the water exiting water purification module 603 has been purified to a level that is safe for peritoneal dialysis. The conductivity sensor 626 ensures that the conductivity of the dialysate is within a predetermined range after the concentrate from the concentrate source 604 is added. The refractive index sensor 627 ensures that the concentration of the osmotic agent is within a predetermined range. The pH sensor 628 ensures that the pH of the peritoneal dialysis solution is within a predetermined range. After the peritoneal dialysis solution passes through the sterilization module comprising the second ultrafilter 609, a pH sensor 629 and a conductivity sensor 630 are used to ensure that the pH or conductivity has not changed during the purification or storage of the dialysis solution in the dialysate container 614. The integrated circulator 610 has a flow meter 631, pressure sensor 632, and temperature sensor 633 to ensure that the dialysate infused into the patient 634 is within the proper flow rate, pressure, and temperature ranges.
Fig. 7A to 7D illustrate a non-limiting embodiment of a peritoneal dialysis solution generation system arranged as a peritoneal dialysis solution generation cabinet 801. Fig. 7A illustrates a perspective view of the peritoneal dialysis solution generation tank 801, fig. 7B illustrates a front view of the peritoneal dialysis solution generation tank 801, fig. 7C illustrates a side view of the peritoneal dialysis solution generation tank 801, and fig. 7D illustrates a rear view of the peritoneal dialysis solution generation tank 801.
A fluid line 805 may connect the water source 804 to the peritoneal dialysis solution generation tank 801. Fluid line 805 may enter top 806 of water source 804 through connector 828. The fluid line 805 is connected to the peritoneal dialysis solution generation flow path through the rear of the peritoneal dialysis solution generation cabinet 801 as described with reference to fig. 1 and 5 to 6 by a connector 832 having a fitting 833 for securing the fluid line 805, as illustrated in fig. 7D. Any of the illustrated fluid lines can be disconnected and removed from the system for cleaning and replacement. If desired, a pump (not shown) can provide a driving force for movement of fluid throughout the peritoneal dialysis solution generation flow path. Water is pumped through the peritoneal dialysis solution generation tank 801 to the water purification module, shown in fig. 7A through 7B as a sorbent cartridge 812. Within the peritoneal dialysis solution generating cabinet 801, water can enter the sorbent cartridge 812 through a conduit (not shown) connected to the bottom of the sorbent cartridge 812. Water exits sorbent cartridge 812 through connector 813 and conduit 814. Osmotic agent from osmotic agent source 815 and ionic concentrate from ionic concentrate source 817 are added to the fluid as described to produce an unsterilized peritoneal dialysis solution. The osmotic agent concentrate is added to the fluid through the paddle connector 816. The ion concentrate is added to the fluid through the paddle connector 818. A concentrate pump (not shown) can provide a driving force to move fluid from a concentrate source into the peritoneal dialysis solution generation flow path inside the peritoneal dialysis solution generation cabinet 801. As described, the system may use a single ion concentrate source instead of the two sources shown in fig. 7A-7B, or may use more than two concentrate sources. The generated peritoneal dialysis solution can then be pumped through a sterilization module (not shown), such as an ultrafilter. A second ultrafilter and/or a UV light source may also be included. An integrated circulator (not shown in fig. 7A-7D) may then pump dialysate through connector 820 into infusion line 819 and into the patient. Fitting 825 allows infusion line 819 to be removed from the system for cleaning or replacement. Waste fluid can be pumped from the system through waste line 807, and waste line 807 is connected to peritoneal dialysis solution production tank 801 through connector 830 with fitting 831. A separate waste line (not shown in fig. 7A-7D) for removing used dialysate from the patient may also be connected to the peritoneal dialysis solution production cabinet 801 and to waste line 807. The waste line 807 enters the waste container 808 through a connector 829 in the top 809 of the waste container 808. Handles 810 and 811 may be included on the water source 804 and waste receptacle 808 for easy removal and storage. Although the peritoneal dialysis solution generation tank 801 is illustrated in fig. 7A through 7D as being on top of the table 826, the peritoneal dialysis solution generation tank 801 can be used on any stable flat surface.
As described, the peritoneal dialysis solution generation flow path can include various sensors for detecting conductivity, pH, refractive index, or other dialysate parameters. The sensors may be contained inside or outside the body of the peritoneal dialysis solution generation tank 801. Fluid lines and valves connecting the components of the peritoneal dialysis solution generation flow path can likewise be positioned inside the cabinet body. As depicted, the top of the peritoneal dialysis solution generation cabinet 801 can have a graphical user interface 802, including a screen 803. Messages from the control system to the user or from the user to the control system may be generated and read through the graphical user interface 802. The user can direct the generation of peritoneal dialysis solution through the graphical user interface 802 and can receive messages from the system through the screen 803. The system may generate an alert to the user, including any problems detected by any of the sensors, and the progress of the peritoneal dialysis solution production. A handle 824 may be included to open the peritoneal dialysis solution generation tank 801 to allow access to the components inside the tank. Handles 821 and 823 may be included to secure fluid lines and power lines when not in use.
The sterile connector 822 illustrated in fig. 7A and 7C may be included to sterilize the waste line 807. During sterilization, the waste line 807 may be disconnected from the waste container 808 and connected to the sterile connector 822. Disinfectant solution from a disinfectant source (not shown in fig. 7A-7D) may then be circulated through the waste line 807 to disinfect the waste line 807. A sterilization connector 827 may be included to sterilize fluid line 805. Fluid line 805 may be connected to disinfection connector 822, and disinfection solution may be circulated through fluid line 805. The drain 834 on the water source 804 and the drain 835 on the waste receptacle 808 allow the water source 804 and the waste receptacle 808 to be emptied without inverting the receptacle.
Fig. 8 illustrates a peritoneal dialysis solution production cabinet 901 using a non-purified water source, a faucet 905 in a sink 904. Although illustrated as a faucet 905 and sink 904, one of ordinary skill in the art will appreciate that any water source may be used. The ability to use municipal or other non-purified water sources allows the peritoneal dialysis solution generation system to be operated in the patient's home without the need to store large amounts of purified water or dialysis solution. Fitting 906 connects water line 907 to faucet 905 or other water source, allowing water line 907 to be connected or disconnected as desired. As described with respect to fig. 1 and 5-6, a pump (not shown) can provide a driving force for movement of fluid throughout the peritoneal dialysis solution generation flow path. Water is pumped through the peritoneal dialysis solution generation tank 901 to a water purification module, shown in fig. 8 as a sorbent cartridge 911. Within the peritoneal dialysis solution generating cabinet 901, water enters the sorbent cartridge 911 through a conduit (not shown) connected to the bottom of the sorbent cartridge 911. Water exits sorbent cartridge 911 through connector 926 and conduit 912. The osmotic agent from osmotic agent source 913 and the ionic concentrate from ionic concentrate source 914 are added to the fluid as described to generate an unsterilized peritoneal dialysis solution. The osmotic agent concentrate is added to the fluid through a paddle connector 916. The ion concentrate is added to the fluid through a paddle connector 915. A concentrate pump (not shown) can provide a driving force to move fluid from a concentrate source into the peritoneal dialysis solution generation flow path inside the peritoneal dialysis solution generation tank 901. As described, the system may use a single ion concentrate source instead of the two sources shown in fig. 8, or may use more than two concentrate sources. The generated peritoneal dialysis solution can then be pumped through a sterilization module (not shown), such as an ultrafilter. A second ultrafilter and/or a UV light source may also be included. An integrated circulator (not shown in fig. 8) can then pump dialysate through connector 918 into the infusion line 917 and into the patient. The fitting 919 allows the infusion line 917 to be removed from the system for cleaning or replacement. Waste fluid may be pumped from the system through a waste line 908, which waste line 908 may be connected to a drain 909 shown in a bathtub 910. A separate drain line (not shown) from the patient may be included to move the used dialysate into the drain pipe 909. Although shown in fig. 8 as a bathtub drain 909, the waste fluid may be delivered to any type of drain, or to a waste receptacle as illustrated in fig. 7A-7D. Although the peritoneal dialysis solution generation tank 901 is illustrated in fig. 8 as being on top of the table 924, the peritoneal dialysis solution generation tank 901 can be used on any stable flat surface. In certain embodiments, the peritoneal dialysis solution generation tank 901 and the patient can be in the same room as the water supply and drain pipe 909. Alternatively, the patient and/or the peritoneal dialysis solution generation tank 901 can be in a separate room with tubing long enough to reach the patient. For longer distances, the tubing should be strong enough to withstand the pressures required to pump fluids over longer distances.
As depicted, the top of the peritoneal dialysis solution generation tank 901 can have a graphical user interface 902, including a screen 903. Messages from the control system to the user or from the user to the control system may be generated and read through the graphical user interface 902. The user can direct the generation of peritoneal dialysis solution through the graphical user interface 902 and can receive messages from the system through the screen 903. The system may generate an alert to the user, including any problems detected by any of the sensors, and the progress of the peritoneal dialysis solution production. A handle 920 may be included to open the peritoneal dialysis solution generation tank 901, allowing access to the components inside the tank. Handles 921 and 923 may be included to secure the fluid lines and power lines when not in use.
A disinfection connector 922 may be included to disinfect the waste line 908. During sterilization, the waste line 908 may be disconnected from the drain pipe 909 and connected to the sterile connector 922. Disinfectant solution from a disinfectant source (not shown in fig. 8) may then be circulated through the waste line 908 to disinfect the waste line 908. A disinfection connector 925 may be included to disinfect the water tube 907. Water line 907 may be disconnected from faucet 905 and connected to disinfection connector 925. The disinfectant solution may be circulated through a water line 907 for disinfection.
Fig. 9 illustrates an alternative non-limiting embodiment of the peritoneal dialysis solution generation flow path 1111. Water from the water source 1101 can be pumped by the system pump 1103 into the peritoneal dialysis solution generation flow path 1111 through the connector 1165. Although shown in fig. 9 as having a spiral top 1166, any method may be used for the water source 1101 to fill and empty the water source 1101. Prior to entering the peritoneal dialysis solution generation flow path 1111, the water can be pumped through the filter 1102 to remove any particulate matter from the water. Alternatively, a dedicated water source, such as a faucet or a municipal water source, may be used in place of the water source 1101. Pressure sensor 1104 measures the pressure upstream of sorbent cartridge 1105. In certain embodiments, the sorbent cartridge 1105 may be replaced with an alternative water purification module comprising a reverse osmosis module, a nanofilter, a combination of ion and anion exchange materials, activated carbon, silica, or silica-based columns. The shading in sorbent cartridge 1105 shows the different layers of sorbent material. However, any order of layers of sorbent material may be used, or the sorbent materials may be mixed. In fig. 9, sorbent cartridge 1105 has a fluid inlet 1164 and a fluid outlet 1163 in the base of sorbent cartridge 1105. In certain embodiments, fluid inlet 1164 and fluid outlet 1163 may instead be located on opposite sides of sorbent cartridge 1105. Filter 1106 can remove particulate matter from the fluid exiting sorbent cartridge 1105.
First conductivity sensor 1107 may measure the conductivity of the fluid exiting sorbent cartridge 1105. One or more infusates may be added to the infusion line 1110 from the ion concentrate source 1109 through the connector 1162 at the T-junction 1150 via the concentrate pump 1112 to the peritoneal dialysis solution generation flow path 1111. The filter 1151 may remove any particulate matter from the infusate concentrate before reaching the peritoneal dialysis solution generation flow path 1111. Alternatively, a valve may be used in place of the T-joint 1150. Secondary conductivity sensor 1108 may measure the conductivity of the fluid after the infusate is added to ensure that the concentration of each infusate is proper. As described, the system may include any number of infusion sources, each having the same or separate infusion pumps and infusion lines. A fluid with a particular known concentration of solute will have a particular electrical conductivity. Thus, the control system in communication with the secondary conductivity sensor 1108 may measure the conductivity of the fluid with the secondary conductivity sensor 1108 to ensure that the conductivity is within a predetermined range of the patient's dialysate prescription. The control system may also adjust the ion concentrate flow rate by adjusting the pump speed of the concentrate pump 1112 based on data received from the secondary conductivity sensor 1108. If the conductivity measured by the secondary conductivity sensor 1108 is below a predetermined range for the dialysate prescription, the control system may increase the ionic concentrate flow rate. If the conductivity measured by the secondary conductivity sensor 1108 is above a predetermined range for the dialysate prescription, the control system may decrease the ionic concentrate flow rate.
A secondary concentrate pump 1115 forming part of a secondary infusion line 1117 may add an osmotic agent to the peritoneal dialysis solution generation flow path 1111 at a T-junction 1156 via the secondary infusion line 1117. Although shown in fig. 9 as a single secondary infusion line 1117, those skilled in the art will appreciate that any number of secondary infusion lines may be used to connect a separate osmotic agent source to the peritoneal dialysis solution generation flow path 1111. The secondary composition sensor 1152 may measure the osmotic agent concentration of the fluid in the secondary infusion line 1117. A control system in communication with the secondary composition sensor 1152 may use the concentration of the osmotic agent in the secondary infusion line 1117 in setting the flow rate of the osmotic agent based on the dialysate prescription. The final osmotic agent concentration in the dialysate will be a function of the osmotic agent concentration in secondary infusion line 1117 and the relative rate of flow of dialysate through peritoneal dialysis solution generation flow path 1111 and secondary infusion line 1117. As illustrated in fig. 9, the system may have multiple osmotic agent sources, including a dextrosaccharide source 1148 fluidly connected to the osmotic agent line by connector 1154 and an icodextrin source 1114 fluidly connected to the osmotic agent line by connector 1160. The user or control system may select the appropriate osmotic agent to use based on the needs of the patient, as described. Filter 1153 may remove particulate matter from the fluid exiting the dextrane source 1148, and filter 1161 may remove the particulate matter form fluid exiting the icodextrin source 1114. Instead of, or in addition to, the source of dextrose 1148 and the source of icodextrin 1114, alternative sources of osmotic agents may be used, including a source of amino acids or a source of glucose, allowing customization of the osmotic agent used. Valve 1116 controls the source from which the osmotic agent is obtained. Alternatively, multiple permeate lines and permeate pumps may be used. The flow meter 1118 measures the flow rate of fluid through the peritoneal dialysis solution generation flow path 1111. The composition sensor 1119 may measure the concentration of an osmotic agent in a fluid as well as an infusion fluid. The composition sensor may comprise a single sensor, or multiple sensors measuring separate fluid parameters. The composition sensors 1152 and 1119 may include refractive index sensors, enzyme-based sensors, and/or pulsed amperometric detection sensors. The composition sensors 1152 and 1119 may also include conductivity sensors, pH sensors, and/or flow meters. The control system may use the composition sensor 1119 and the secondary conductivity sensor 1108 to determine the concentration of ions and osmotic agents in the peritoneal dialysis solution generation flow path 1111. If the osmotic agent concentration or ion concentration is outside of a predetermined range of the dialysate prescription, the system can generate an alarm and/or stop treatment. The system can also adjust the ion concentrate flow rate and/or the osmotic agent flow rate to bring the ion concentration and the osmotic agent concentration within a predetermined range of the dialysate prescription.
The heater 1120 heats the fluid in the peritoneal dialysis solution generation flow path 1111 to the patient's temperature. The temperature sensor 1121 measures the temperature of the fluid and can be used by the control system to control the heater 1120 to heat the fluid to a temperature between about 25 ℃ and about 40 ℃. In preferred embodiments, the desired temperature may be 37 ± 2 ℃ or between 36.5 and 37.25 ℃. The control system may monitor the temperature and shut off flow or generate an alarm if the temperature is outside a desired range. In certain embodiments, the control system may shut off flow at temperatures equal to, greater than, about 41 ℃. The pressure sensor 1122 measures the pressure of the fluid prior to entering the dialysate sterilization module.
The dialysate sterilization module can include a first ultrafilter 1123 and a second ultrafilter 1124 fluidly connected by a fluid line 1159. The fluid flows through two ultrafilters to remove any chemical or biological contaminants. Waste fluid may exit first ultrafilter 1123 through fluid line 1130 and exit second ultrafilter 1124 through fluid line 1129. Valves 1149 and 1128 control the movement of fluid between first and second ultrafilters 1123 and 1124 and into waste line 1131, waste line 1131 fluidly connected to fluid line 1130 at T-joint 1167. Valves 1149 and 1128 may be used to regulate fluid movement from the ultrafilters 1123 and 1124 to ensure sufficient pressure for ultrafiltration. If the pressure in ultrafilter 1124 drops below a necessary value, valve 1128 can be closed, thereby preventing fluid from moving from ultrafilter 1123 into fluid line 1130 and increasing the pressure in ultrafilter 1124. The waste line 1131 is fluidly connected to the waste line 1134 at T-junction 1168 and to the waste reservoir 1133 by way of connector 1169, or to a drain. Although shown with a screw top 1170 and spigot 1171, those skilled in the art will appreciate that alternative methods for filling and emptying the waste reservoir 1133 may be used.
The fluid exiting the second ultrafilter 1124 passes through a valve 1125. Valve 1125 may direct fluid into fluid line 1113 and integrated circulator or into fluid line 1126 to add to the dextrose source 1148 and the icodextrin source 1114 via T-joint 1155. Fluids may be added to the source of dextrorotatory sugars 1148 and the source of icodextrin 1114 to dissolve the solid icodextrin and solid dextrose prior to generating the peritoneal dialysis solution.
The fluid line 1113 may contain a pressure sensor 1127 to ensure that the fluid pressure is within predetermined limits before entering the integrated circulator. Valve 1135 controls the movement of fluid from the sterilization module. Valve 1136 controls the movement of fluid into and out of the integrated circulator via circulator line 1138.
The circulator line 1138 can include a second temperature sensor 1139 to ensure that the peritoneal dialysis solution is at the correct temperature prior to infusion into the patient 1147. An air detector 1141 is included to detect any air that may otherwise be introduced into the patient 1147. A bubble trap (not shown) may be included to remove any detected air. The flow meter 1143 measures the flow rate of fluid in the circulator line 1138 and can be used to control the amount of peritoneal dialysis solution infused into the patient 1147. A pressure sensor 1142 may be included to ensure that the fluid pressure in the circulator line 1138 is within predetermined limits for infusion into the patient 1147. The catheter 1140 may be connected to the circulator line 1138 at connection 1144. In certain embodiments, a heparin syringe 1146 may be included to add heparin or other medication to the peritoneal dialysis solution. The filter 1145 removes any particulate matter prior to infusion of the peritoneal dialysis solution into the patient 1147.
After the dwell period, the spent peritoneal dialysis solution can be drained from the patient 1147 through the circulator line 1138. The drain pump 1132 can provide a driving force to drain the used peritoneal dialysis solution. The used peritoneal dialysis solution passes through valves 1136 and 1137 and into drain line 1134, which drain line 1134 can be fluidly connected to a waste reservoir 1133 or drain.
As illustrated in fig. 9, the dialysate preparation system can be fluidly connected to the dialysate preparation system. The dialysate preparation system can include conductivity sensors 1107 and 1108, an ion concentrate source 1109, one or more osmotic agent sources illustrated as an icodextrin source 1114 and a dextrose source 1148, infusion lines 1110 and 1117, and composition sensors 1152 and 1119, these devices shown as dashed box 1172. The dialysate generation system can also include a water purification module, illustrated in fig. 9 as a sorbent cartridge 1105, and a sterilization module, illustrated in fig. 9 as an ultrafilter 1123 and 1124.
As illustrated in fig. 9, the secondary infusion line 1117 may be fluidly connected to the second ultrafilter 1124 of the sterilization module by a fluid line 1126. In certain embodiments, a solid source of osmotic agent and/or infusion fluid may be used. The solid source can be placed in the dextral sugar source 1148 and the icodextrin source 1114. To generate an osmotic agent concentrate, water from water source 1101 can be added to dextrosaccharide source 1148 and icodextrin source 1114, thereby generating a concentrate of known concentration. To ensure that the icodextrin source 1114 and the dextransuccharide source 1148 remain free of chemical or biological contamination, the water may first be passed through a sterilization module comprising a first ultrafilter 1123 and a second ultrafilter 1124 prior to being added to the osmotic agent source. Water from the water source 1101 can be pumped through the sorbent cartridge 1105 and the peritoneal dialysis solution generation flow path 1111. The heater 1120 heats the water and is controlled by the control system based on data received from the temperature sensor 1121. The control system may control the heater 1120 to heat the water to a set temperature, which may affect the solubility of the osmotic agent and allow the osmotic agent concentrate to have a known concentration. The water is then pumped through first ultrafilter 1123, through fluid line 1159 and second ultrafilter 1124. Valve 1125 may direct water from second ultrafilter 1124 via secondary infusion line 1117 through fluid line 1126 and into each of icodextrin source 1114 and dextrosaccharide source 1148 to produce a contaminant-free osmotic agent concentrate. As described, the peritoneal dialysis solution generation system can include any number of osmotic agent sources, and the second ultrafilter 1124 can be fluidly connected to each osmotic agent source. Although not illustrated in fig. 9, the second ultrafilter 1124 also may be fluidly connected to an ion concentrate source 1109 to generate an ion concentrate free of chemical or biological contamination. The heater 1120 may heat the water before it passes through the first ultrafilter 1123 and the second ultrafilter 1124. The use of hot water to dissolve the osmotic agent may allow for faster and more complete dissolution to minimize the system preparation time before treatment can begin. In certain embodiments, the water may be heated to between about 25 ℃ to about 90 ℃ to minimize the dissolution time of the PD fluid components while also minimizing the formation of glucose degradation products. The osmotic agent concentrate can then be mixed with the purified water in the peritoneal dialysis solution generation flow path 1111 and the temperature can be diluted by the incoming flow. Vibrating plate 1157 may stir the solution in the icodextrin source 1114 and vibrating plate 1158 may stir the solution in the dextrane source 1148 to further accelerate dissolution of the osmotic agent. A vibrating plate or other means of agitating the ion concentrate source may be included. Those skilled in the art will appreciate that alternative means of agitating the ion concentrate may be used, including agitators or other mixers.
Those skilled in the art will appreciate that various combinations and/or modifications and variations may be made in the described systems and methods depending on the particular needs of the operation. Furthermore, features illustrated or described as part of aspects of the invention may be used in aspects of the invention either alone or in combination, or following a preferred arrangement of one or more of the elements described.
Claims (20)
1. A dialysate preparation system for peritoneal dialysis, comprising:
a first fluid line fluidly connected to the water purification module;
at least one source of ion concentrate fluidly connected to the first fluid line by a first infusion line; the first infusion line has a first concentrate pump;
one or more osmotic agent sources fluidly connected to the first fluid line by one or more secondary infusion lines; the secondary infusion line comprises a secondary concentrate pump forming part of the one or more secondary infusion lines;
wherein at least one or more conductivity sensors are positioned in the first fluid line upstream of the first infusion line; at least one or more secondary conductivity sensors are positioned in the first fluid line downstream of the first infusion line and upstream of the secondary infusion line; and at least one composition sensor is positioned in the first fluid line downstream of the one or more secondary infusion lines;
the first fluid line is fluidly connectable to an integrated circulator.
2. The dialysate preparation system of claim 1 further comprising at least one secondary composition sensor positioned in the one or more secondary infusion lines.
3. The dialysate preparation system of claim 2 further comprising a control system in communication with the composition sensor and the secondary composition sensor, the control system measuring an osmotic agent concentration at the composition sensor and the secondary composition sensor.
4. The dialysate preparation system of claim 3, the control system controlling a flow rate of an osmotic agent based on the composition sensor and the secondary composition sensor.
5. The dialysate preparation system of claim 1 further comprising at least one flow meter in the first fluid line.
6. The dialysate preparation system of claim 1 wherein at least two osmotic agent sources are fluidly connected to the one or more secondary infusion lines.
7. The dialysate preparation system of claim 6 further comprising one or more valves fluidly connecting the at least two osmotic agent sources to the secondary infusion line.
8. The dialysate preparation system of claim 1, further comprising a control system in communication with the conductivity sensor and the secondary conductivity sensor, the control system controlling a flow rate of an ionic concentrate based on the conductivity sensor and the secondary conductivity sensor.
9. The dialysate preparation system of claim 1 further comprising at least one pH sensor in the first fluid line.
10. The dialysate preparation system of claim 2 wherein the composition sensor and/or the secondary composition sensor is selected from the group consisting of a refractive index sensor, an enzyme-based sensor, and a pulsed amperometric detection sensor.
11. The dialysate preparation system of claim 1 further comprising a second fluid line fluidly connecting the secondary infusion line to a sterilization module.
12. A method of generating a peritoneal dialysis solution comprising:
a) pumping water from a water source into a first fluid line through a water purification module;
b) measuring a first conductivity of the fluid in the first fluid line;
c) pumping ion concentrate from at least one ion concentrate source into the first fluid line through a first infusion line;
d) measuring a second conductivity of the fluid in the first fluid line downstream of the first infusion line;
e) pumping an osmotic agent concentrate from an osmotic agent source into the first fluid line through a second infusion line;
f) measuring a first osmotic agent concentration in the first fluid line downstream of the second infusion line.
13. The method of claim 12, further comprising the step of measuring a second osmotic agent concentration in the second infusion line.
14. The method of claim 12, further comprising the steps of pumping fluid from the first fluid line into a sterilization module and pumping the fluid from the sterilization module into an integrated circulator.
15. The method of claim 12, further comprising receiving a dialysate prescription; and setting an ionic concentrate flow rate and an osmotic agent flow rate based on the dialysate prescription.
16. The method of claim 13, wherein the steps of setting an ion concentrate flow rate and an osmotic agent flow rate are performed by a control system in communication with a first concentrate pump in the first infusion line and a second concentrate pump in the second infusion line.
17. The method of claim 15, wherein the control system sets the osmotic agent flow rate based on the first osmotic agent concentration and the dialysate prescription.
18. The method of claim 15, further comprising the step of generating an alarm if the first osmotic agent concentration and/or the second conductivity are outside a predetermined range of the dialysate prescription.
19. The method of claim 13, further comprising any one or both of:
a) generating the ion concentrate by pumping purified water from a sterilization module into the ion concentrate source; and/or
b) Generating the osmotic agent concentrate by pumping purified water from the sterilization module into the osmotic agent source.
20. The method of claim 19, wherein either or both of the following are present:
a) the step of generating the ion concentrate further comprises agitating the ion concentrate after pumping the purified water into the ion concentrate source, heating the purified water before pumping the purified water into the ion concentrate source, or a combination thereof; and/or
b) The step of generating the osmotic agent concentrate further includes agitating the osmotic agent concentrate after pumping the purified water into the osmotic agent source, heating the purified water before pumping the purified water into the osmotic agent source, or a combination thereof.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15/723,676 | 2017-10-03 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HK40003063A true HK40003063A (en) | 2020-04-03 |
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